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Wuhan uni-pharma bio-tech co.,ltd
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Sterile Promethazine Hydrochloride Injection Medicine B.P. 50mg / 2ml

Sterile Promethazine Hydrochloride Injection Medicine B.P. 50mg / 2ml

Brand Name : Uni-pharma
Model Number : 50mg/2ml
Certification : GMP
Place of Origin : China
MOQ : 500000Amps
Price : Negotiate
Payment Terms : L/C, D/A, D/P, T/T
Delivery Time : After packaging confirmed 30 days
Packaging Details : 10 Amps/Box
Applications : Internal Medicine
Usage method : Injectable
Applicable people : Adults/Children
Form : Liquid
Shape : Injection
Type : Organic Chemcials
Pharmaceutical methods : Chemical Synthesis
Specification : 50mg/2ml
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Sterile Promethazine Hydrochloride Injection Medicine B.P. 50mg / 2ml


[Drug Descripition]


Promethazine hydrochloride (promethazine hydrochloride injection) injection, is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (promethazine hydrochloride injection) (10H-phenothiazine-10-ethanamine, N, N, α-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula:


Promethazine hydrochloride structural formula illustration

Each mL contains either 25 mg or 50 mg promethazine hydrochloride (promethazine hydrochloride injection) with 0.1 mg edetate disodium, 0.04 mg calcium chloride, 0.25 mg sodium metabisulfite, and 5 mg phenol in water for injection. The pH range is 4.0 to 5.5, buffered with acetic acid-sodium acetate, and it is sealed under nitrogen.

Promethazine hydrochloride (promethazine hydrochloride injection) injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.


Indication

Promethazine hydrochloride (promethazine hydrochloride injection) is indicated for the following conditions:

  1. Amelioration of allergic reactions to blood or plasma.
  2. In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
  3. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
  4. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
  5. Active treatment of motion sickness.
  6. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
  7. As an adjunct to analgesics for the control of postoperative pain.
  8. Preoperative, postoperative, and obstetric (during labor) sedation.
  9. Intravenously in special surgical situations, such as repeatedbronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.

[DOSAGE AND ADMINISTRATION]

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use promethazine hydrochloride (promethazine hydrochloride injection) if solution has developed color or contains precipitate.

To avoid the possibility of physical and/or chemical incompatibility, consult specialized literature before diluting with any injectable solution or combining with any other medication. Do not use if there is a precipitate or any sign of incompatibility.

Important Notes on Administration

The preferred parenteral route of administration for promethazine hydrochloride (promethazine hydrochloride injection) is by deepintramuscular injection. The proper intravenous administration of this product is well-tolerated, but use of this route is not without some hazard. Not forsubcutaneous administration.

INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY (see WARNINGS, Inadvertent Intra-arterial Injection). SUBCUTANEOUS INJECTION IS CONTRAINDICATED, AS IT MAY RESULT IN TISSUE NECROSIS (seeCONTRAINDICATIONS).

Injection into or near a nerve may result in permanent tissue damage.

When used intravenously, promethazine hydrochloride (promethazine hydrochloride injection) should be given in concentration no greater than 25 mg/mL at a rate not to exceed 25 mg per minute; it is preferable to inject through the tubing of an intravenous infusion set that is known to be functioning satisfactorily.

Allergic Conditions

The average adult dose is 25 mg. This dose may be repeated within two hours if necessary, but continued therapy, if indicated, should be via the oral route as soon as existing circumstances permit. After initiation of treatment, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The average adult dose for amelioration of allergic reactions to blood or plasma is 25 mg.

Sedation

In hospitalized adult patients, nighttime sedation may be achieved by a dose of 25 to 50 mg of promethazine hydrochloride (promethazine hydrochloride injection) .

Nausea and Vomiting

For control of nausea and vomiting, the usual adult dose is 12.5 to 25 mg, not to be repeated more frequently than every four hours. When used for control of postoperative nausea and vomiting, the medication may be administered either intramuscularly or intravenously and dosage of analgesics and barbiturates reduced accordingly.

Preoperative and Postoperative Use

As an adjunct to preoperative or postoperative medication, 25 to 50 mg promethazine hydrochloride (promethazine hydrochloride injection) in adults may be combined with appropriately reduced doses of analgesics and atropine-like drugs as desired. Dosage of concomitant analgesic or hypnotic medication should be reduced accordingly.

Obstetrics

Promethazine hydrochloride (promethazine hydrochloride injection) in doses of 50 mg will provide sedation and relieve apprehension in the early stages of labor. When labor is definitely established, 25 to 75 mg (average dose, 50 mg) promethazine hydrochloride (promethazine hydrochloride injection) may be given intramuscularly or intravenously with an appropriately reduced dose of any desired narcotic. If necessary, promethazine hydrochloride (promethazine hydrochloride injection) with a reduced dose of analgesic may be repeated once or twice at four-hour intervals in the course of a normal labor. A maximum total dose of 100 mg of promethazine hydrochloride (promethazine hydrochloride injection) may be administered during a 24-hour period to patients in labor.

Pediatric Patients

Promethazine hydrochloride (promethazine hydrochloride injection) tablets and promethazine hydrochloride (promethazine hydrochloride injection) rectal suppositories are contraindicated for children under 2 years of age. (See WARNINGS, Use in Pediatric Patients).

In pediatric patients 2 years of age and older, the dosage should not exceed half that of the suggested adult dose. As an adjunct to premedication, the suggested dose is 0.5 mg per lb. of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Antiemetics should not be used in vomiting of unknown etiology in pediatric patients.


[SIDE EFFECTS]

CNS Effects

Drowsiness is the most prominent CNS effect of the drug. Extrapyramidal reactions may occur with high doses; this is almost always responsive to a reduction in dosage. Other reported reactions include dizziness, lassitude,tinnitus, incoordination, fatigue, blurred vision, euphoria, diplopia, nervousness, insomnia, tremors, convulsive seizures, oculogyric crises, excitation, catatonic-like states, hysteria, and hallucinations.

Cardiovascular Effects

Tachycardia, bradycardia, faintness, dizziness, and increases and decreases in blood pressure have been reported following the use of promethazine hydrochloride (promethazine hydrochloride injection) . Venous thrombosis at the injection site has been reported. INTRA-ARTERIAL INJECTION MAY RESULT IN GANGRENE OF THE AFFECTED EXTREMITY. (SeeWARNINGS, Inadvertent Intra-arterial Injection.)

Gastrointestinal Effects

Nausea and vomiting have been reported, usually in association with surgical procedures and combination drug therapy.

Allergic Reactions

These include urticaria, dermatitis, asthma, and photosensitivity. Angioneurotic edema has been reported.

Other Reported Reactions

Leukopenia and agranulocytosis, usually when promethazine has been used in association with other known marrow-toxic agents, have been reported. Thrombocytopenic purpura and jaundice of the obstructive type have been associated with the use of promethazine. The jaundice is usually reversible on discontinuation of the drug. Subcutaneous injection has resulted in tissuenecrosis. Nasal stuffiness may occur. Dry mouth has been reported.

Paradoxical Reactions (Overdosage)

Hyperexcitability and abnormal movements, which have been reported in pediatric patients following a single administration of promethazine hydrochloride (promethazine hydrochloride injection) , may be manifestations of relative overdosage, in which case, consideration should be given to the discontinuation of promethazine hydrochloride (promethazine hydrochloride injection) and to the use of other drugs. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.


[OVERDOSE]

Signs and symptoms of overdosage range from mild depression of thecentral nervous system and cardiovascular system to profound hypotension, >respiratory depression, and unconsciousness.

Stimulation may be evident, especially in pediatric patients and geriatric patients. Convulsions may rarely occur. A paradoxical reaction has been reported in pediatric patients receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine-like and symptoms—dry mouth, fixed, dilated pupils, flushing, etc., as well as gastrointestinal symptoms, may occur.


[Treatment]

Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine hydrochloride (promethazine hydrochloride injection) are not reversed by naloxone.

Avoid analeptics, which may cause convulsions. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of levarterenol or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated withanticholinergic antiparkinson agents, diphenhydramine, or barbiturates. Oxygen may also be administered. Limited experience with dialysis indicates that it is not helpful.


[CONTRAINDICATIONS]

Promethazine hydrochloride (promethazine hydrochloride injection) is contraindicated in comatose states and in patients who have demonstrated an idiosyncrasy or hypersensitivity to promethazine or other phenothiazines.

Under no circumstances should promethazine hydrochloride (promethazine hydrochloride injection) be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene.

Promethazine hydrochloride (promethazine hydrochloride injection) should not be given by the subcutaneous route; evidence of chemical irritation has been noted, and necrotic lesions have resulted on rare occasions following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscular injection.

This monograph has been modified to include the generic and brand name in many instances.



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